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SPECIFICATION (ASTM D3578 & EN 455)
| Dimension | Standard specification |
|---|---|
| Cuff | Min. 0.06 mm |
| Palm | Min. 0.08 mm |
| Finger | Min. 0.10 mm |
| Length | Min. 240 mm |
| Physical properties (Unaged) | Standard specification |
|---|---|
| Tensile strengths | Min. 18 MPa |
| Elongation | Min. 650% |
| Force at break | Min. 6.0 N |
| Physical properties (Aged) | Standard specification |
|---|---|
| Tensile strengths | Min. 14 MPa |
| Elongation | Min. 500% |
| Force at break | Min. 6.0 N |
REGULATIONS STANDARD & COMPLIANCE
| U.S. FDA 510(k) | ISO 9001 |
| MDR (EU) 2017/745 | ISO 14001 |
| AS/NZS 4011 | ISO 45001 |
| ISO 11193-1 | MDSAP (US, Canada, Australia) |
| ISO 13485 | PPER (EU) 2016/425 |
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